Concomitant Medications:

Preprocedure use of an ADP antagonist was 99.6% (clopidogrel 12%, prasugrel 27%, and ticagrelor 61%)

Principal Findings:

Overall, 1,829 patients were randomized. The mean age was 63 years, 29% were women, and 13% had diabetes. Radial artery access was used in 80%, thrombectomy was performed in 59%, and a drug-eluting stent was implanted in 80%. The use of abciximab was 13% in the bivalirudin group versus 15% in the heparin group. The median activated clotting time (ACT) was 251 seconds in the bivalirudin group versus 224 seconds in the heparin group.

The primary efficacy outcome of all-cause mortality, stroke, reinfarction, or unplanned revascularization occurred in 8.7% of the bivalirudin group versus 5.7% of the heparin group (p = 0.01).

The primary safety outcome of major bleeding occurred in 3.5% of the bivalirudin group vs. 3.1% of the heparin group (p = 0.59).

Interpretation:

Among patients with STEMI undergoing PPCI, with selective use of abciximab (i.e., bailout) and preprocedure dual antiplatelet therapy, the use of bivalirudin was inferior to unfractionated heparin. Bivalirudin was associated with an increase in adverse cardiovascular events, due to an increase in MI/stent thrombosis. There was no major bleeding reduction with bivalirudin, which is often touted as the predominant reason to use this agent; however, catheterization was mostly performed by radial access.

Strengths of this pragmatic trial include enrollment of virtually all patients with STEMI. Also, the dose of heparin was lower than what had been used in some previous trials (100-140 U/kg), which is more consistent with current practice. Although this was a large and well-designed trial, it was conducted from a single center and used open-label design (independent blinded adjudication of outcomes).